Actívatexto: Advancing smoking cessation and physical activity among Latino adults. Study protocol for a randomized clinical trial

Introduction: Latinos, the largest minority population in the U.S., experience significant tobacco-related health disparities. Prior work by our team led to the development of Decídetexto, a culturally accommodated text messaging smoking cessation intervention that demonstrated efficacy in a randomized controlled trial (RCT). However, most participants did not meet recommended levels of physical activity [at least 150 min of moderate to vigorous physical activity (MVPA) per week], and the intervention did not leverage its potential benefits for smoking cessation, despite evidence suggesting that MVPA may enhance cessation rates. Objectives: To describe the methodology of a randomized clinical trial evaluating the efficacy of Actívatexto, a culturally accommodated mobile health intervention that combines smoking cessation and physical activity, versus Decídetexto, a mobile intervention that solely promotes smoking cessation, on smoking abstinence (cotinine-verified 7-day point prevalence abstinence) at Month 6 among Latinos who smoke. Methods: Latino adults who smoke and do not meet physical activity guidelines (N = 408) will be randomized to one of two conditions: 1) Actívatexto or 2) Decídetexto. Actívatexto includes four components: 1) a bilingual text messaging program, 2) wearable devices to monitor physical activity, 3) access to nicotine replacement therapy, and 4) a centralized data management dashboard. We will recruit eligible Latino individuals through community and clinic-based approaches. All participants will complete follow-up assessments at Month 3 and Month 6. Discussion: This study will provide critical evidence on the synergistic effects of integrating physical activity into smoking cessation interventions and inform scalable, culturally responsive strategies to reduce tobacco-related disparities among Latinos. Trial registration: ClinicalTrials.gov identifier: NCT06926608.